MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number 1012453-12

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Internal file number - (b)(4). The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The nc trek rx coronary dilatation catheters, instruction for use states that if resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter. The investigation determined the reported difficulty positioning the device appears to be related to circumstances of the procedure; however, the reported shaft separation appears to be related to user error. There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Excessive force. The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The other nc trek referenced is filed under a separate medwatch report.

Event Description

It was reported that during a left anterior descending coronary artery procedure, two 4. 0 x 12 mm nc trek dilatation catheters were attempted to be used in a kissing balloon technique. Both dilatation catheters were inserted into a 6french guide catheter. As the dilatation catheters were inserted, resistance was noted. It was thought that the guide wires became tangled and the dilatation catheters had resistance advancing over the guide wires. An attempt was made to force the dilatation catheters through the guide catheters, but the shafts separated. Both separated nc trek catheters were easily removed. There was no adverse patient effect or a clinically significant delay. No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7180846
• MDR Text Key: 264245821
• Report Number: 2024168-2018-00272
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1012453-12
• Device Lot Number: 70822G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial